USER-DEFINED STRUCTURED TESTING FOR USE IN DIABETES CARE

• US 20120289802A1
• Filed: 05/13/2011
• Published: 11/15/2012
• Est. Priority Date: 05/13/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Bousamra, Steven A.
• Granted Patent: US 10,448,869 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS

Abstract

A method is provided for constructing a structured test having user-defined adherence criteria. The method includes: presenting a patient with a plurality of contextual criterion for a structured test; receiving selection of one or more contextual criterion from the plurality of contextual criterion; and constructing a structured test that includes the contextual criterion selected by the patient. During administration of the structured test, each of the contextual criteria selected by the patient is evaluated. Sample data acquired during the structured test is reported as compliant when each of the context criterion selected by the patient was met during the administration of the structured test or tagged as non-compliant when at least one contextual criterion was not met during the administration of the structured test

Claims

1. A method for measuring glucose levels of a patient, comprising:

receiving from the patient an objective for a structured test;

identifying a test template that corresponds to the objective from a plurality of predefined test templates;

presenting the patient with a plurality of contextual criterion for the identified test template;

receiving selection of one or more contextual criterion by the patient from the plurality of contextual criterion;

constructing a structured test that includes the contextual criterion selected by the patient and in accordance with the identified test template; and

administering the structured test to the patient, including prompting the patient to provide a sample of blood to a glucose meter, such that the steps of the method are implemented by a computer processor of a device.

2. The method of claim 1 further comprises presenting the patient with a plurality of objectives for conducting a structured test, such that each of objectives correlates to one of a plurality of test templates.

3. The method of claim 1 further comprises presenting the patient with a set of contextual criterion for the selected test template such that contextual criterion associated with a given test template differ from contextual criterion associated with other test template amongst the plurality of predefined test templates.

4. The method of claim 1 wherein administering the structured test further comprises presenting a query to the patient for each contextual criterion, receiving replies to the queries from the patient and associating the replies with data collected during the structured test.

5. The method of claim 1 wherein administering the structured test to the patient further comprises prompting the patient to input a sample of blood into a glucose meter before and after a given event within a window of time that encapsulates the given event and presenting a query to the patient for contextual data regarding another event that differs from the given event.

6. The method of claim 5 further comprises presenting a query to the patient for contextual data regarding another event that occurs outside the window of time.

7. The method of claim 5 further comprises prompting the patient to input a sample of blood into the glucose meter at a time that occurs outside of the window of time.

8. The method of claim 1 further comprises defining adherence criterion for the structured test and reporting data collected during the structured test when the adherence criterion for the structured test is met.

9. The method of claim 8 further comprises defining the adherence criterion based on the selected contextual criterion.

10. A method for collecting biomarkers from a patient, comprising:

presenting a patient with a plurality of contextual criterion for a structured test;

receiving selection of one or more contextual criterion by the patient from the plurality of contextual criterion;

constructing a structured test that includes the contextual criterion selected by the patient;

administering the structured test to the patient, including collecting biomarker data from the patient using a collection device;

evaluating whether a given contextual criterion selected by the patient has been met during the administration of the structured test; and

tagging sample data acquired during the structured test by the collection device as non-compliant when the given contextual criterion was not met during the administration of the structured test.

11. The method of claim 10 further comprises reporting sample data acquired during the structured test as compliant when the given context criterion selected by the patient was met during the administration of the structured test.

12. The method of claim 10 wherein administering the structured test further comprises presenting a query to the patient for each contextual input, receiving replies to the queries from the patient and associating the replies with data collected during the structured test.

13. The method of claim 10 wherein administering the structured test to the patient further comprises prompting the patient to provide a sample of blood into a glucose meter before and after a given event within a window of time that encapsulates the given event and presenting a query to the patient for contextual data regarding another event that differs from the given event.

14. The method of claim 13 further comprises presenting a query to the patient for contextual data regarding another event that occurs outside the window of time.

15. The method of claim 13 further comprises prompting the patient to input a sample of blood into the glucose meter at a time that occurs outside of the window of time.

16. A method for measuring glucose levels of a patient, comprising:

prompting the patient to provide a sample of blood to a glucose meter before and after a given event within a window of time that encapsulates the given event;

determining a blood glucose measure from the sample of blood input to the glucose meter;

presenting a query to the patient for contextual data regarding another event that occurs outside the window of time;

receiving a reply to the query from the patient; and

associating the reply with the blood glucose measure, where the steps of prompting, presenting, and associated are implemented by a computer processor of a device.

17. The method of claim 16 further comprises presenting the patient with a plurality of contextual criterion related to a structured test being administered to the patient;

receiving selection of one or more contextual criterion by the patient from the plurality of contextual criterion; and

presenting queries to the patient for each of the contextual criterion.

18. The method of claim 16 further comprises constructing a structured test that includes the contextual criterion selected by the patient;

administering the structured test to the patient;

evaluating whether a given contextual criterion selected by the patient have been met during the administration of the structured test; and

tagging sample data acquired during the structured test as non-compliant when the given contextual criterion was not met during the administration of the structured test.

19. The method of claim 16 further comprises prompting the patient to input a sample of blood into the glucose meter at a time that occurs outside of the window of time

20. A diabetes management device, comprises:

a test configuration module configured to receive an objective for a structured test from a user of the device and operable to identify a test template that corresponds to the objective from a plurality of predefined test templates, the test configuration module in data communication with a display of the device to present a plurality of contextual criterion for the identified test template and operable to receive selection of one or more contextual criterion by the user from the plurality of contextual criterion;

a test builder module configured to receive the contextual criterion selected by the user and construct a structured test that includes the contextual criterion selected by the user and in accordance with the identified test template; and

a test administration module operable to administer the structure test to a patient, where the test configuration module, the test builder module and the test administration module are implemented as computer-executable instructions by a computer processor of the device.

21. The diabetes management device of claim 20 further comprises a blood glucose measuring module that selectively measures blood glucose in a blood sample.

22. The diabetes management device of claim 20 wherein the test configuration module presents the user with a plurality of objectives for conducting a structured test, such that each of objectives correlates to one of the plurality of predefined test templates.

23. The diabetes management device of claim 20 wherein the test configuration module presents the user with a set of contextual criterion for the selected test template such that contextual criterion associated with a given test template differs from contextual criterion associated with another test template amongst the plurality of predefined test templates.

24. The diabetes management device of claim 20 wherein the test administration module presents a query to the user for each contextual criteria, receives replies to the queries from the user and associates the replies with data collected during the structured test.

25. The diabetes management device of claim 20 wherein the test administrator module evaluates whether a given contextual criterion selected by the patient have been met during the administration of the structured test;

and reports sample data acquired during the structured test as compliant when the given contextual criterion selected by the patient was met during the administration of the structured test.

26. The diabetes management device of claim 20 wherein the test administrator module tags sample data acquired during the structured test as non-compliant when the given contextual criterion was not met during the administration of the structured test.

27. A method for collecting blood glucose measures from a patient, comprising:

presenting a patient with a plurality of contextual criterion for a structured test, where the structured test includes prompting the patient to provide a sample of blood to a glucose meter before and after a given event;

receiving selection of one or more contextual criterion by the patient from the plurality of contextual criterion;

constructing a structured test that includes the contextual criterion selected by the patient;

administering the structured test to the patient multiple times over a period of time, thereby acquiring a sample instance of blood glucose measures for each structured test in a series of administered structured tests;

evaluating whether a given contextual criterion selected by the patient has been met during the administration of a given structured test; and

tagging sample data acquired during the given structured test as non-compliant or discarding the sample data when the given contextual criterion was not met during the administration of the given structured test.

28. The method of claim 27 further comprises reporting sample data acquired during the structured test as compliant when the given context criterion selected by the patient was met during the administration of the given structured test.

29. The method of claim 27 further comprises presenting a query to the patient for the one or more contextual criteria during administration of the structured test, receiving replies to the queries from the patient and associating the replies with data collected during the structured test.

30. The method of claim 27 further comprises presenting a query to the patient for contextual data regarding another event that occurs outside the window of time.

31. The method of claim 27 further comprises analyzing sample instances acquired over the series of the structured tests and presenting results from the analysis to the patient.

32. The method of claim 31 further comprises prompting the patient to categorize the sample instance for a given structure test and disregarding the sample instance for the given structured test from subsequent analysis when the sample instance is categorized by the patient as atypical.

33. The method of claim 31 further comprises presenting a query to the patient for at least one contextual criterion during administration of a given structured test, receiving a reply to the query from the patient, prompting the patient to categorize the sample instance for the given structure test and disregarding the sample instance for the given structured test from subsequent analysis when the sample instance is categorized as atypical by the patient.

34. The method of claim 27 further comprises

guiding the patient through a first series of structured tests constructed using the contextual criteria selected by the patient;

deriving a baseline blood glucose measure from the sample instances acquired during the first series of structured tests;

prompting the patient to change a variable associated with the first series of structured tests;

guiding the patient through a second series of structured test, where the second series of structured tests have a value for the variable different from the first series of structured tests but otherwise constructed using the contextual criteria selected by the patient; and

deriving a changed blood glucose measure from the sample instances acquired during the second series of structured tests.

35. The method of claim 34 further comprises presenting results from the first and second series of structured tests to the patient, including a comparison of the baseline blood glucose measure and the changed blood glucose measure.

36. The method of claim 34 further comprises analyzing sample instances acquired during the first and second series of structured tests and presenting results from the analysis to the patient